MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for HEMOTHERM DUAL RESERVOIR COOLER/HEATER 55552 manufactured by Cincinnati Sub-zero Products, Inc..
[184079626]
Cincinnati hemotherm dual reservoir cooler/heater was identified as being defective. During precheck of the device, the defect was identified. When turning the unit on, it immediately turns off. Upon review of the device by biomedical engineering, it was determined to be a problem with the power board. A week prior, a different cincinnati hemotherm dual reservoir cooler/heater was identified as having the same problem with the power board. Both devices had new power boards installed on [date redacted] in response to the urgent medical device correction letter received by the company. Defect was identified before reaching the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853330 |
| MDR Report Key | 9853330 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-30 |
| Report Date | 2020-01-31 |
| Date Reported to FDA | 2020-01-31 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOTHERM DUAL RESERVOIR COOLER/HEATER |
| Generic Name | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS |
| Product Code | DWJ |
| Date Received | 2020-03-19 |
| Model Number | 55552 |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUB-ZERO PRODUCTS, INC. |
| Manufacturer Address | 12011 MOSTELLER RD 3RD FLOOR BLUE ASH OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |